Memantine in Preventing Side Effects in Patients Undergoing Whole-Brain Radiation Therapy for Bra… (NCT00566852) | Clinical Trial Compass
CompletedPhase 3
Memantine in Preventing Side Effects in Patients Undergoing Whole-Brain Radiation Therapy for Brain Metastases From Solid Tumors
United States554 participantsStarted 2008-03
Plain-language summary
RATIONALE: Memantine may be able to decrease side effects caused by whole-brain radiation therapy. It is not yet known if memantine is effective in preventing side effects caused by whole-brain radiation therapy.
PURPOSE: This randomized phase III trial is studying memantine to see how well it works compared to a placebo in preventing side effects caused by whole-brain radiation therapy in patients with brain metastases from solid tumors.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed diagnosis of a solid tumor malignancy within the past 5 years
* If the original histologic proof of malignancy is \> 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic metastasis or brain metastasis)
* Brain metastases must be visible on contrast-enhanced MRI or a contrast enhanced CT scan (for patients unable to undergo MRI within the past 28 days)
* Patients unable to undergo MRI imaging because of non-compatible devices are eligible, provided the contrast-enhanced CT scans are obtained and are of sufficient quality
* Patients who had undergone radiosurgery or surgical resection and are planning adjuvant whole-brain radiotherapy do not have to have visible disease but do need a baseline MRI
* Must have stable systemic disease (i.e. no evidence of systemic disease progression within the past 3 months)
* Patients with brain metastases at initial presentation are eligible and do not need to demonstrate 3 months of stable scans
PATIENT CHARACTERISTICS:
Inclusion
* Karnofsky performance status 70-100%
* Serum creatinine ≤ 3 mg/dL and creatinine clearance ≥ 30 mL/min
* Total bilirubin ≤ 2.5 mg/dL
* Blood urea nitrogen (BUN) \< 20 mg/dL
* Mini-mental status exam score ≥ 18
* Negative serum pregnancy test
* Fertile patients must practice adequate contraception
Exclusion
* Severe, active co-morbidity, defined as follows:
* Unstable angina and/or congestiv…
What they're measuring
1
Change in the Hopkins Verbal Learning Test - Revised for Delayed Recall (HVLT-R-delayed Recall) at 24 Weeks
Timeframe: Baseline and 24 weeks from the start of drug treatment